Label: CURAD MAXIMUM STRENGTH TRIPLE ANTIBIOTIC- bacitracin, neomycin, polymyxin b, pramoxine hydrochloride ointment

  • NDC Code(s): 53329-031-01
  • Packager: Medline Industries, LP
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated September 26, 2022

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  • Active ingredients (in each gram)

    Bacitracin 500 units

    Neomycin 3.5 mg

    Polymyxin B 10,000 units

    Pramoxin hydrochloride 10 mg

  • Purposes

    First aid antibiotic

    First aid antibiotic

    First aid antibiotic

    Pain reliever

  • Uses

    • First aid to help prevent infection in and temporarily relieves pain due to
    • minor cuts
    • scrapes
    • burns
  • Warnings

    • For external use only

    Do not use

    • if allergic to any of the ingredients
    • in or near the eyes
    • on large areas of the body

    Ask a doctor before use if you have

    • deep or puncture wounds
    • animal bites
    • serious burns

    Stop use and ask a doctor if

    • you need to use longer than 1 week
    • condition lasts or gets worse
    • symptoms last for more than 7 days, or clear up and come back within a few days
    • a rash or other allergic reaction develops

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center immediately.

  • Directions

    Adults and children 2 years and older:

    • clean affected area
    • apply a small amount (equal to the surface area of tip of finger) on area 1 to 3 times daily
    • may be covered with a sterile bandage.

    Children under 2 years: ask a doctor

  • Other information

    Store at controlled room temperature 68º-77ºF (20º-25ºC).

  • Inactive ingredient

    petrolatum

  • Manufacturing Information

    Manufactured for:

    Medline Industries, LP

    Three Lakes Drive Northfield, IL 60093 USA

    Made in USA of domestic and imported materials
    www.medline.com

    1-800-MEDLINE (633-5463)

    REF: CUR001232

    V1 RD22SFZ

  • Package Label

    Label V1 RD22SFZ

  • INGREDIENTS AND APPEARANCE
    CURAD MAXIMUM STRENGTH TRIPLE ANTIBIOTIC 
    bacitracin, neomycin, polymyxin b, pramoxine hydrochloride ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-031
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B10000 [USP'U]  in 1 g
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE3.5 mg  in 1 g
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN ZINC500 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-031-011 in 1 BOX12/01/2019
    128.4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B12/01/2019
    Labeler - Medline Industries, LP (025460908)
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